Author of

• 12592

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  P3.10 - Poster Session 3 - Chemotherapy (ID 210)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 2
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12601

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    P3.10-009 - Phase II study of bevacizumab in combination with carboplatin plus paclitaxel as first-line chemotherapy for non-squamous non-small cell lung cancer with malignant pleural effusion (ID 902)

    09:30 - 09:30  |  Author(s): M. Tamiya
    • Abstract

    Background
    Vascular endothelial growth factor (VEGF) plays an important role in non small cell lung cancer (NSCLC) with malignant pleural effusion (MPE), but there are little evidence regarding the efficacy of bevacizumab (Bev) with carboplatin-paclitaxel (CP) for treatment of NSCLC with MPE. Therefore, we prospectively evaluated the efficacy and safety of Bev and CP in non-squamous (SQ) NSCLC patients with MPE.Vascular endothelial growth factor (VEGF) plays an important role in non small cell lung cancer (NSCLC) with malignant pleural effusion (MPE), but there are little evidence regarding the efficacy of bevacizumab (Bev) with carboplatin-paclitaxel (CP) for treatment of NSCLC with MPE. Therefore, we prospectively evaluated the efficacy and safety of Bev and CP in non-squamous (SQ) NSCLC patients with MPE.

    Methods
    Chemotherapy-naive non-SQ NSCLC patients with MPE were eligible to participate. Pleurodesis before chemotherapy was not allowed. In the first cycle, the treated patients received only CP to prevent Bev-induced wound healing delayed after chest drainage. Subsequently, they received 2–6 cycles of CP with Bev. Patients who completed more than 4 cycles of CP and Bev without disease progression or severe toxicities continued to receive Bev alone as a maintenance therapy. The primary endpoint was overall response, although an increase in MPE was allowed in the first cycle. The VEGF levels in plasma and MPE were measured at baseline and the VEGF levels in plasma were measured after 3 cycles of chemotherapy.

    Results
    Between September 2010 and June 2012, 23 patients were enrolled. The overall response rate was 60.8%, the disease control rate was 87.0%, and one patient was not evaluated response because of sudden death after 1 cycle treatment. Sixteen patients received maintenance therapy, following a median of 3 cycles. The median progression-free survival and the median overall survival were 7.1 months (95% CI, 5.6 - 9.4 months) and 11.7 months (95% CI, 7.4 – 16.6 months). Almost all patients experienced severe hematological toxicities, including ≥ grade 3 neutropenia. And there was no patient who experienced severe bleeding events. The median baseline VEGF levels in MPE was 1798.6 (range; 223.4 - 35,633.4) pg/mL. The VEGF levels in plasma showed a significant decrease after 3 chemotherapy cycles (baseline; 513.6 ± 326.4 pg/mL, post chemotherapy; 25.1 ± 14.1 pg/mL, p < 0.01), regardless of efficacy of CP with Bev.

    Conclusion
    The combination of CP with Bev was confirmed to be effective and tolerable in chemotherapy-naïve non-SQ NSCLC patients with MPE.

  • 12607

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    P3.10-015 - Final analysis of dose escalation study of carboplatin plus pemetrexed followed by maintenance pemetrexed for elderly patients (≥75 years old) with advanced non-squamous non-small cell lung cancer (ID 1349)

    09:30 - 09:30  |  Author(s): M. Tamiya
    • Abstract

    Background
    This study was designed to determine the recommended dose of carboplatin plus pemetrexed in elderly (≥75 years old), chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer (NSCLC).Patients and methods: Patients received escalated doses of carboplatin and pemetrexed every 3 weeks for 4 cycles. Patients with an objective response and stable disease continued pemetrexed therapy until disease progression or unacceptable toxicity was observed.

    Methods
    Patients received escalated doses of carboplatin area under the concentration–time curve (AUC) of 4 (cohort 0) or 5 (cohort 1) or 6 (cohort 2) and pemetrexed 500mg/m2 every 3 weeks for 4 cycles. Patients with an objective response and stable disease continued pemetrexed therapy until disease progression or unacceptable toxicity was observed.

    Results
    In cohort 0, a dose-limiting toxicity (DLT) was not observed in three patients, and no DLTs were seen in the first three patients of cohort 1. In cohort 2, DLTs were observed in three of the seven patients: two of grade 4 thrombocytopenia and one of grade 3 febrile neutropenia. And in additional cohort 1, no DLTs were seen in the next four patients. Therefore, the combination of carboplatin at an area under the concentration–time curve (AUC) of 5, plus 500 mg/m[2 ]pemetrexed, was determined to be the recommended dose for elderly patients (≥75 years old) with advanced non-squamous NSCLC. Of a total of 17 patients, 10 received a median of 5 cycles of pemetrexed maintenance therapy without unexpected or cumulative toxicities. No complete responses and 8 partial responses were observed, and the study had an overall response rate of 47.1%. The median progression-free survival time was 5.5 monthes (95% confidence interval [CI], 2.4–8.9 monthes) and the median overall survival time was 12.6 monthes (95% CI, 7.4–17.9 monthes) in he final analysis of this study.

    Conclusion
    Figure 1 This combination was a tolerable and effective regimen, and recommended dose was carboplatin (AUC of 5) / pemetrexed (500 mg/m2) every 3 weeks, in chemotherapy-naïve, elderly (≥75 years old) patients with advanced non-squamous NSCLC.